June 28, 2017

A combination regimen of ixazomib plus lenalidomide and dexamethasone conferred deep and durable responses among patients with newly diagnosed multiple myeloma, according to clinical study results presented at the Congress of European Hematology Association.

“Data showed that patients had deep responses on single-agent therapy and median PFS of more than 2 years,” Shaji K. Kumar, MD, professor of medicine at Mayo Clinic in Rochester, Minnesota, said in a press release. “We remain committed to gathering additional data of ixazomib in this investigational, maintenance setting.”

In the current analysis, Kumar and colleagues evaluated long-term safety and efficacy data from patients who did not discontinue treatment in the trial to receive stem cell transplantation.

“Based on an increasing body of evidence that long-term therapy may improve clinical outcomes, this [phase 1/phase 2] trial focused on continuous treatment of patients with newly diagnosed multiple myeloma,” Kumar said in the press release.

As of October 18, 2016, patients achieved an overall response rate of 80% a complete with very good partial response rate of 63%; and complete response rate of 32%. The median duration to first response was 0.95 months and median time to complete response was 5.6 months.

Patients achieved a median PFS of 25.3 months. The median OS had not been reached at a median follow-up of 56 months; however, the researchers estimated 3-year OS of 87%.

Nearly three-quarters of patients (74%) experienced grade 3 or worse treatment-related adverse events and 26% of patients had treatment-related serious events. The most common treatment-related grade 3 or higher adverse events observed during the induction period included neutropenia (17%), thrombocytopenia (17%) and fatigue (14%). However, grade 3 or worse rash (7%) and peripheral neuropathy (5%) appeared uncommon.

One treatment-related death occurred due to respiratory syncytial viral pneumonia.

After completing all cycles of induction therapy, 25 patients received maintenance therapy. These patients achieved a 100% ORR — including a very good partial response rate of 44% and complete response rate of 32% — at the end of the induction period.

At data cutoff, ORR remained at 100%, with the very good partial response rate at 32% and complete response rate increasing to 44%. Median PFS for patients who received maintenance therapy was 24 months.

Common adverse events appeared confined to the induction period. No patients experienced grade 3 or worse peripheral neuropathy or rash during maintenance. – byMelinda Stevens

Disclosure: Kumar reports research funding to the Mayo Clinic for clinical trials from AbbVie, Celgene, Janssen, Merck, Sanofi and Takeda; and consultant roles with Kesios, Noxxon and Skyline. Please see the abstract for a list of all other researchers’ relevant financial disclosures.

A combination regimen of ixazomib plus lenalidomide and dexamethasone conferred deep and durable responses among patients with newly diagnosed multiple myeloma, according to clinical study results presented at the Congress of European Hematology Association.

“Data showed that patients had deep responses on single-agent therapy and median PFS of more than 2 years,” Shaji K. Kumar, MD, professor of medicine at Mayo Clinic in Rochester, Minnesota, said in a press release. “We remain committed to gathering additional data of ixazomib in this investigational, maintenance setting.”

In the current analysis, Kumar and colleagues evaluated long-term safety and efficacy data from patients who did not discontinue treatment in the trial to receive stem cell transplantation.

“Based on an increasing body of evidence that long-term therapy may improve clinical outcomes, this [phase 1/phase 2] trial focused on continuous treatment of patients with newly diagnosed multiple myeloma,” Kumar said in the press release.

As of October 18, 2016, patients achieved an overall response rate of 80% a complete with very good partial response rate of 63%; and complete response rate of 32%. The median duration to first response was 0.95 months and median time to complete response was 5.6 months.

Patients achieved a median PFS of 25.3 months. The median OS had not been reached at a median follow-up of 56 months; however, the researchers estimated 3-year OS of 87%.

Nearly three-quarters of patients (74%) experienced grade 3 or worse treatment-related adverse events and 26% of patients had treatment-related serious events. The most common treatment-related grade 3 or higher adverse events observed during the induction period included neutropenia (17%), thrombocytopenia (17%) and fatigue (14%). However, grade 3 or worse rash (7%) and peripheral neuropathy (5%) appeared uncommon.

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One treatment-related death occurred due to respiratory syncytial viral pneumonia.

After completing all cycles of induction therapy, 25 patients received maintenance therapy. These patients achieved a 100% ORR — including a very good partial response rate of 44% and complete response rate of 32% — at the end of the induction period.

At data cutoff, ORR remained at 100%, with the very good partial response rate at 32% and complete response rate increasing to 44%. Median PFS for patients who received maintenance therapy was 24 months.

Common adverse events appeared confined to the induction period. No patients experienced grade 3 or worse peripheral neuropathy or rash during maintenance. – byMelinda Stevens

Disclosure: Kumar reports research funding to the Mayo Clinic for clinical trials from AbbVie, Celgene, Janssen, Merck, Sanofi and Takeda; and consultant roles with Kesios, Noxxon and Skyline. Please see the abstract for a list of all other researchers’ relevant financial disclosures.